Key Market Overview:
The downstream processing market is expected to grow at a CAGR of 13.7% during the forecast period (2023-2030), with a projected market size of USD 71.78 billion by 2030. The market was valued at USD 25.7 billion in 2022. Factors driving market growth include the increasing demand for biopharmaceuticals, rising investments in R&D activities, and technological advancements in downstream processing equipment. Additionally, the growing adoption of single-use technologies and increasing focus on personalized medicine are expected to contribute to market growth.
Downstream processing includes the stage of biomanufacturing that starts with the collection of cell culture medium containing the active pharmaceutical ingredient (API) from the bioreactor. The biomanufacturing concludes with the production of a concentrated and purified product that is suitable for final formulation and packaging.
Further, downstream processing is referred to the set of techniques used to purify, recover, and isolate the target product from the fermentation or bioprocess. The goal of downstream processing is to obtain a pure, stable, and high-quality product that meets the desired specifications for pharmaceutical, biotechnology, or industrial applications. The downstream processing steps typically follow the upstream processing steps such as fermentation or cell culture and are generally divided into several stages, including cell separation, clarification, concentration, purification, and formulation.
Moreover, such downstream processing is critical to the production of large and complex molecules of used to treat diseases such as cancer and autoimmune disorders. For instance, according to a report published by the National Institute of Environmental Health Sciences, over 80 autoimmune diseases including type-1 diabetes, lupus, multiple sclerosis, and rheumatoid arthritis affect more than 24 Billion people in the United States. Thus, the demand for downstream processing for the development of therapeutics for such autoimmune diseases is expected to witness a significant increase during the forecast period.
Increased adoption of downstream processing methods for the creation of therapeutics used for various chronic and autoimmune disease treatments fuels the market growth. Further, growing investments in advancements in downstream processing technology such as chromatography, filtration, and centrifugation to make the process more efficient and cost-effective also boosts the wide adoption of downstream processing by biopharmaceutical companies. Moreover, favorable preference by such biopharmaceutical companies for outsourcing their manufacturing processes to contract manufacturing organizations (CMOs) also propels the demand for downstream processing, which plays a crucial role in the pharmaceutical manufacturing process.
High capital due to involvement of complex and expensive equipment in downstream processing such as chromatography systems, ultrafiltration, and microfiltration systems, and centrifuges hampers the market growth. Further, growing environmental concerns related to downstream processing that generates a significant amount of waste, such as buffer solutions and chromatography resins, also limit the wide adoption of such processing due to expensive disposal in an environmentally friendly manner.
The scope of exploring new purification methods such as buffer dilution systems, membrane technology, flow-through and continuous chromatography, and continuous purification systems is expected to offer lucrative opportunities for market growth in terms of developing new classes of therapeutics. Also, an emerging focus on technological advancements for new formulations to increase the stability of biomolecules without the need for refrigeration is anticipated to offer creative opportunities for the downstream processing market growth during the forecast period.
Downstream Processing Report Coverage:
Downstream Processing Market Segmentation:
|Report Attributes||Report Details|
|Market Size in 2030 (USD Billion)||71.78 Billion|
|CAGR (2023-2030)||13.7 %|
|By Technique||Purification, Separation (Filtration, Centrifugation), Concentration (Evaporation, Membrane Filtration), Others|
|By Product||Chromatography Systems and Resins, Automated Columns, Filters, Centrifuges, Evaporators, Dryers, Others (Consumables, and Accessories)|
|By Application||Antibiotic Production, Hormone Production, Enzyme Production, Vaccine Production, Others (Interferons, Blood Coagulation Factors, Anticoagulants, Immunoglobulin)|
|By End Use||Contract Manufacturing Organizations (CMOs), Biopharmaceutical Manufacturers, Others|
- Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia]
- Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey]
- North America [United States, Canada, Mexico]
- Middle East & Africa [GCC, North Africa, South Africa]
- South America [Brazil, Argentina, Columbia, Chile, Peru]
|Key Players||Thermo Fisher Scientific Inc., Merck KGaA, Esco Micro Pte. Ltd., Cytiva (Danaher Corporation), Sartorius AG, 3M,Boehringer Ingelheim International GmbH, Corning Corporation, Asahi Kasei Bioprocess America, Inc., Eppendorf SE|
The technique segment is divided into purification, separation, concentration, and others. The purification segment accounted for held a dominant position in 2022 and is expected to maintain the lead during the forecast period. The high demand for purified proteins in various downstream applications such as interaction studies, biophysical characterization, immunization, structural analysis, cell assays, and others boosts segmental growth, further fueling the market growth. Moreover, separation segment is also anticipated to account for a significant share contribution to the downstream processing market growth during the projected period in terms of effective separation of bioreactors from the cells of the product of interest.
The product segment is categorized into chromatography systems and resins, automated columns, filters, centrifuges, evaporators, dryers, and others. The chromatography resins and automated columns contributed highest shares to the market growth in 2022. Various manufacturers opt for introducing columns and chromatography resins to meet increased requirements that range from screening to lab-scale production of biopharmaceuticals. Thus, such high demand for resins and columns for providing robust and consistent performance for processing flexibility supports segmental growth. Further, filters are estimated to account for the market growth in terms of value and volume. Large-scale usage of such filters in cell harvesting processes to capture unwanted impurities, intermediate purification of the sample, along with polishing stages is expected to boost the segmental growth in coming years.
The application segment is separated into antibiotic production, enzyme production, hormone production, vaccine production, and others. The antibiotic production segment dominated the market shares with the highest share contribution and is projected to maintain the lead over the forecast period. Downstream processing witnesses an increased demand for the removal of insoluble compounds, typically cells from fermentation broth, with the help of filtration and centrifugation in the processing of monoclonal antibiotics such as infliximab and abciximab. Thus, growing demand and consumption of antibiotics such as penicillin V, tetracyclines, cephalosporins, and others support segmental growth. Also, the vaccine production segment is expected to contribute substantial shares to the market growth during the forecast period due to the need for attenuated vaccines for create a strong and enduring immune response.
By End User
The end-use segment comprises contract manufacturing organizations (CMOs), biopharmaceutical manufacturers, and others. The biopharmaceutical manufacturers segment accounted for highest share contribution to the market growth in 2022. High usage of downstream processing for purification and recovery of biosynthetic products such as antibodies, and enzymes, as a specialized field of biochemical engineering, supports the market demand in biopharmaceutical manufacturers. Furthermore, the contract manufacturing organizations (CMOs) segment is also estimated to support the market growth in terms of volume. The wide access to strong connections with varied clinical trial patient data in different countries supports the demand for such downstream processing in terms of offering biosimilars and biologics through CMOs.
The regional segment includes North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held a dominant position in 2022 in terms of highest shares contribution to the downstream processing market statistics. The factors attributable to market growth in North America are the established presence of market players along with high government expenditures on research and production of novel drug interventions.
Moreover, Asia Pacific is also projected to support the growing market in terms of volume. Rising adoption of technologies for drug development and testing due to increased spending on healthcare is anticipated to create favorable circumstances for market growth in the Asia Pacific region.
Downstream Processing Market Competitive Landscape:
The market for downstream processing is expected to witness significant growth in the coming years due to increasing demand for biologics and the development of new and advanced technologies for downstream processing. Several market players focus on introducing products with increased technological advancements along with strategic mergers and acquisitions to cater the growing needs of healthcare. Mentioned are market players that operate in the latest market circumstances–
• Thermo Fisher Scientific Inc.
• Merck KGaA
• Esco Micro Pte. Ltd.
• Cytiva (Danaher Corporation)
• Sartorius AG
• Boehringer Ingelheim International GmbH
• Corning Corporation
• Asahi Kasei Bioprocess America, Inc.
• Eppendorf SE
• In February 2021, 3M Health Care released a latest product called 3M Polisher ST, which is a single-use membrane chromatography solution with two AEX-functional media that work together to enhance the polishing process for biologics drug manufacturing. This innovative product is designed to replace reusable AEX polishing columns and offers a more efficient and cost-effective solution.
• In March 2023, Thermo Fisher Scientific introduced a new range of HPLC columns with low-flow capabilities, that are designed to improve the separation efficiency and stability of complex biological samples in proteomics and biopharmaceutical research laboratories. This new line of columns is aimed at improving the overall performance of separation in several types of samples.
• In February 2023, Elektrofi, a biotech company specializing in drug formulation and delivery, entered into a contract manufacturing agreement with Thermo Fisher Scientific to manufacture its subcutaneous products with ultra-high concentration. The usage of Elektrofi\'s proprietary microparticle technology allows for small-volume injections of biologics, such as monoclonal antibodies and other large-molecule drugs, with the goal of enabling patients to receive treatment outside of hospitals or infusion centers.